Zirconium, acetate lactate oxo ammonium complexes

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-01-16 to 2008-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, scientifically sound GLP study performed according to OECD Guideline 423 and EU Method B.1 tris. However, 6 animals were dosed at once rather than dosing in steps with 3 animals per steps

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate provided by Groupe Interministeriel Des Produits Chimiques

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium dioxide

Cas Number:

1314-23-4

Molecular formula:

ZrO2

IUPAC Name:

Zirconium dioxide

Constituent 2

Reference substance name:

Zirconium dioxide

EC Number:

215-227-2

EC Name:

Zirconium dioxide

IUPAC Name:

215-227-2

Details on test material:

- Name of test material (as cited in study report): CC10 Zirconium Oxide
- Physical state: white powder
- Analytical purity: >98% (considered at 100% for the study)
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle ¿France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: beteween 188g and 207 g
- Fasting period before study: 1 day
- Housing: Three healthy female rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: foodstuff provided ad libitum; food was removed at D-1 and then redistributed 4 hours after the test item administration.
- Water: tap-water from public distribution system provide ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 degree C
- Humidity (%): 39 and 55%
- Air changes (per hr): not applicable
- Photoperiod (hrs dark / hrs light): 12 hours daily


IN-LIFE DATES: From: 2008-02-05 To: 2008-02-20

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight


DOSAGE PREPARATION (if unusual): The animals of treated group, received an effective dose of 2000 mg/kg body weight of the test item, diluted in distilled water and administered by gavage under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.
Weight changes were calculated and recorded.
- Necropsy of survivors performed: yes; Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
- Other examinations performed: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item.
Observations and a mortality report were then carried out every day for 14 days.

Statistics:

no data

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test substance were observed.

Body weight:

The body weight evolution of the animals remained normal throughout the study.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Other findings:

no data

Applicant's summary and conclusion

Conclusions:

The LD50 of CC10 Zirconium Oxide is higher than 5000 mg/kg body weight by oral route in the rat.